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The Effects of Pharmacotherapy on Brain Mechanisms Underlying Cocaine Dependence.

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ClinicalTrials.gov Identifier: NCT00396734
Recruitment Status : Suspended (Grant was not renewed)
First Posted : November 7, 2006
Last Update Posted : June 10, 2010
Sponsor:
Information provided by:
Hadassah Medical Organization

Brief Summary:
The overall aim of this project is to use an advanced brain imaging technique, PET, in order to monitor the progress of pharmacotherapy with modafinil or topiramate for cocaine dependence in methadone-maintained patients who use cocaine in addition. Comparisons will be made within the cocaine dependent methadone maintained subjects, between the start and end of treatment, and between the two medications. This is the first systematic research study of pharmacological treatment for cocaine dependence in Israel. This study is of major clinical use, with implications for the treatment of cocaine dependence in poly-drug abusers in Israel. Successful pharmacotherapy for cocaine dependence is expected in reduction in cue-induced subjective craving and in glucose metabolism in brain areas elicited by cocaine craving. Metabolic activity in regions that are activated by craving should be correlated with dopamine DRD2 receptor occupancy in all patients.

Condition or disease Intervention/treatment
Opioid-Related Disorders Cocaine-Related Disorders Drug: Provigil (Modafinil) Drug: Topamax (Topiramate)

Detailed Description:

SPECIFIC AIMS

  1. To try to elucidate the brain mechanisms underlying cocaine dependence and craving in co-morbid cocaine-dependent patients. For this purpose we shall trigger craving for cocaine by exposure to a videotape showing cocaine use and then measure brain metabolic activity using Positron Emission Tomography (PET) and [18F] Fluorodeoxyglucose (FDG)
  2. To evaluate dopamine binding in the brain in the early stage, and at the end of treatment. For this purpose the patients will undergo brain imaging of the dopamine receptor DRD2 by using PET with [11C] raclopride. This is a well established procedure for quantifying the effects of drugs such as amphetamine and cocaine on the brain.
  3. To investigate the association between subjective measures of craving for cocaine and the level of dopamine DRD2 receptor occupancy in the brain.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Modafinil and Topiramate on Brain Mechanisms Underlying Cue-induced Cocaine Craving and Dependence in Methadone Maintained Cocaine Dependent Patients.
Study Start Date : April 2007
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Provigil (Modafinil)
    Increase from 100mg to 400mg during 1 month of treatment
    Drug: Topamax (Topiramate)
    Increase from 25mg to 200mg in one month (double every week)


Primary Outcome Measures :
  1. Changes in cue-induced brain glucose metabolic activity (FDG) in PET after treatment. [ Time Frame: 1 month ]
  2. Changes in DRD2 receptor density measured by 11 C Raclopride in PET after treatment. [ Time Frame: 1 month ]
  3. Nr.of drug-free urine samples, time to first drug use, duration of longest abstinent period. [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Craving and psychosocial functioning (e.g., employment status, criminal behavior). [ Time Frame: 1 month ]


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Methadone-maintained cocaine-dependent patients use between 1g to 2g a day; 1 to 3 times a week

Exclusion Criteria:

  • use more than 2g a day; 5 times a week to everyday
  • Subjects who are diagnosed as suffering from psychotic illness according to DSM-IV (Axis 1)22, or with a history of CNS disease, a history of infection that might affect CNS (HIV, syphilis, cytomegalovirus, herpes), or a history of head injury with loss of consciousness,pregnant women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00396734


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Study Director: Aviv M Weinstein, Ph.D Hadassah Medical Organization
Principal Investigator: Roland Chisin, M.D Hadassah Medical Organization

Responsible Party: Dr Arik Zukert, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00396734     History of Changes
Other Study ID Numbers: 281006-HMO-CTIL
First Posted: November 7, 2006    Key Record Dates
Last Update Posted: June 10, 2010
Last Verified: June 2010

Keywords provided by Hadassah Medical Organization:
Imaging
cocaine
methadone
craving
PET
FDG
D2
Modafinil
Topiramate

Additional relevant MeSH terms:
Disease
Opioid-Related Disorders
Cocaine-Related Disorders
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Methadone
Topiramate
Modafinil
Armodafinil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Analgesics, Opioid
Narcotics
Analgesics
Antitussive Agents
Respiratory System Agents